Agenda

CCALC FDA Dialogue Session 2023 Welcome_Beatriz Rocha-Dominic Chiapperino (pdf)

Topic 1 Translation and Discordant Findings_Silvia Calderon (pdf)

Topic 2 HAP Selecting Margins for Different Positive Controls_Denise Milovan (pdf)

Topic 2 Enhancement HAP population_Ling Chen (pdf)

Topic 3 Challenges with Adverse Events_Cindi Arons (pdf)

Topic 3 AEs and Analysis_Steven Galati FDA (pdf)

Topic 4 Behavioral Economics for Abuse Liability Testing_Neil Varshneya (pdf)

Topic 4 Behavioral Economics_Steven Hursh (pdf)

Topic 5 Abuse Assessment of Psychedelics_Katherine Bonson (pdf)

Topic 5 Clinical Considerations for Psychedelic HAP Studies_Beatrice Setnik (pdf)